DPS has published the SSH standard ISO 15378:2017/Amd 1:2024 "Primary packaging materials for medical devices - Specific requirements for the implementation of ISO 9001:2015, with reference to good manufacturing practice (GMP) - Amendment 1

The standard defines the requirements for a quality management system, where an organization: a) must consistently provide products and services that meet customer requirements, applicable legal and regulatory requirements and b) aims to increase customer satisfaction through effective implementation of the system, including processes for improving the system and ensuring compliance with customer requirements, applicable legal and regulatory requirements.